Jul 28, 2022 | Drug and Device Corner, Drugs, Medical Devices
EAS bids a fond farewell to Mr. Bryan Coleman, and welcomes Mrs. Lisa El-Shall as our new Sr. Director Pharmaceutical and Medical Device Consulting Services. Lisa can be reached at lelshall@easconsultinggroup.com, 571-447-5504. The FDA has finalized the UDI draft...
Jul 28, 2022 | EASeNews, Under the Microscope
An extra day of shelf-life could save billions of dollars in wasted food. A 2014 study discovered that $2.64 billion could be saved annually if food waste could be reduced by giving products an extra day of shelf-life. The USDA also discovered in a 2010 study that 31%...
Jul 26, 2022 | FDA and USDA Regulatory Update
What You Need to Know FDA’s use of Remote Regulatory Assessments (RRA), originally developed during the COVID-19 health emergency, is being expanded. Announced in a Draft Guidance for Industry on July 22, 2022, FDA intends to use mandatory and voluntary RRAs as part...
Jul 6, 2022 | Drugs, EASeNews, Extra Article, Medical Devices
EAS Consulting Group is pleased to welcome Lisa El-Shall to the EAS management team. As Senior Director for Drug and Device Services, she will be responsible for advising clients on FDA regulatory and GMP compliance matters related to pharmaceutical and medical device...
Jul 6, 2022 | Drug and Device Corner, Drugs, Medical Devices
The FDA is tightening up the validation process in their NDC drug listing system CDER Direct. Prior to 2022, Relabelers and Repackers were able to list their products NDC/label without identifying the source NDC. As of 2022, the drug listing of a repackaged or...
Jul 3, 2022 | Cosmetics, Dietary Supplements, Drugs, EAS in Action, EAS in the News Cosmetics, EAS in the News Dietary Supplements, EAS in the News Drugs, EAS in the News Medical Device, EASeNews, Medical Devices
EAS Consultant, Tamika Cathey, is featured in Tablets and Capsules magazine with an article on establishing an effective environmental monitoring program. Contamination is costly, with recalls and fines for problematic products in the hundreds of millions. EAS offers...